Associate Director, Gene Therapy Pilot PlantLocation Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Associate Director of Gene Therapy Pilot Plant will be responsible for supporting the design/build effort for a 2000L fed batch Pilot Plant. The successful candidate is responsible for leading a department of Managers, Supervisors and operations staff, working cross functionally with Process Development and Manufacturing support and technology (MSAT) to produce viral vectors to support Research studies and for Phase I/II clinical trials. Key member of the Gene Therapy team reporting to Sr. Director of Viral Vector Production.
ATTRIBUTES and RESPONSIBILITIES
A key role for this position will be to work in close collaboration with PD and MSAT to produce research materials for Pre-clinical studies. The role will require an understanding of the science behind the process and will require the ability to scientifically collaborate with Process Development and jointly execute studies. The role will also require the development of staff, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable.
The Associate Director is responsible for leading daily activities in the new Pilot Plant. The position may require off hours support when needed.
- Knowledge and experience in biological processes / viral vector production operations (Cell Culture and Purification)
- Strong understanding of process development, engineering, and technology of biotechnology, processes, equipment and facilities
- Accountable for production operations, planning plant activities, and headcount models.
- Assist Process Development in establishing manufacturable large-scale operations with a focus on Commercial Processes
- Work closely with process development and MSAT to ensure all clinical and non-clinical deliverables are scheduled and budgeted to support the clinical development plan; e.g. CMC, toxicology, regulatory affairs, biostatistics, and data management
- Participation in design and decision making regarding Process Flow and Operations for New Product Introduction (NPI)
Quality (For Clinical Production)
Oversee development of documentation for production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices
- Anticipate and addresses inspection issues that impact plant operations
- Participate in determining appropriate quality standards
- Maintains a high level of compliance through effective monitoring and reporting of key quality metrics
- Ensure timely execution of CAPA, Deviations, change control and continuous improvement initiatives
- Leader for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plant
- Identify key areas for change and alignment and mobilize organization to make changes happen
- Influence and/or develop broad-based programs and initiatives to meet executive level vision and mission
- Must collaborate with multiple departments and assist in developing a clear unified voice for the team
- Provide effective leadership through:
- Collaboration with the ability to work cross functionally with process sciences
- Assess and manage performance of direct reports, team and self
- Create an environment where collaboration, productivity and efficiency are achieved and recognized
- Build long-term development and succession planning
- Develop and administer budgets, schedules, objectives and goals
- Communicate, interact and influences with Leadership Teams and functional department heads to set strategy and shared objectives
- Strong analytical skills and excellent written and verbal communication skills
- Ability to perform in a rapidly changing development environment
Desired Ph.D. in Life Sciences, or equivalent experience, with experience in viral vector production.
- 12+ years of directly related industry experience, including at least 6+ years with proven leadership
- Proven track record in commercial/clinical biological processing
- Strong Process Development or MSAT experience a plus
Knowledge and experience with viral vector related biology and/or manufacturing a plus.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.